Whether you’re in the early stages of pre-clinical work or marketing a well-established therapy, there are a host of stakeholders that will influence your treatment’s success. At Optum Life Sciences, our deep domain expertise and connections to other sectors across health care give us insight into these players’ needs and challenges. Over the years, as we’ve helped pharmaceutical, biotechnology, medical device and diagnostic companies develop holistic evidence generation strategies, we’ve seen some critical themes emerge.
In your own evidence planning, consider these top questions that patients, providers, payers and regulators are looking to answer.
Patients
Patients want access to care across a wider range of locations, including the home — and they expect their clinical histories to guide treatment.
Questions they ask:
- How much of the cost will I need to cover to receive this treatment?
- How are you capturing my experiences of this medical condition, outside of electronic health records (EHR) and claims?
- How does my doctor know which treatment is right for me?
Providers
Providers are diversifying their trusted sources of evidence, both online and at the point of care.
Questions they ask:
- How can your product help fill current gaps in care?
- How do patients using your product compare to patients using the competitor’s product?
- How do I know which patients will benefit most from your treatment?
Payers
Payers want greater alignment between reimbursement and value, especially for emerging high-cost precision therapies.
Questions they ask:
- Are there medical cost offsets associated with your treatment?
- How are you appropriately selecting comparators and measuring outcomes?
- For curative therapies or medications that address chronic conditions, how are you accounting for the gap between when a treatment is delivered and when its benefits are realized?
Regulators
Regulators expect more evidence, while also signaling a greater openness to a wider range of sources — most notably, real-world evidence (RWE).
Questions they ask:
- What have you done to show that your treatment is safe and effective across different demographic populations?
- How are you monitoring post-authorization safety?
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